ISIDD 2016

February 22-24, 2016

International Symposium on Integrated Drug Development: Chemistry, Manufacturing and Control (CMC)

National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar, Mohali (Punjab) 160062. (India)




Final Schedule for February 22 to 24, 2016

Uploaded on 17-Feb-2016

Short Course on "Significance of preformulation in developability and deliverability" (February 22, 2016)                               Last Updated on 13-January-2016

Details of Symposium -List of Topics alongwith Speakers (February 23-24,  2016)     

Updated on 20-Jan-2016

   Announcement and Registration Form    (Updated on 01-Jan-2016)

(Updated on 18-12-2015)

Uploaded on 17-Dec-2015


A unique two day Symposium preceded by a short course on "Significance of pre-formulation in pharmaceutical development and deliverability" conceived, developed and organized by experienced industry professionals. The symposium will provide a scientifically sound platform for exchange of knowledge, sharing and promotion of excellence in the areas of drug development with specific emphasis on Chemistry, Manufacturing and Control elements. The short course will focus on fundamental concepts on pre-formulation aspects including topics on stability, solubility, solid state properties, basic principles of PK/PD, and use of in-silico models in predicting bioavailability. The major objective of this blended cross discipline learning is to provide the attendees with a comprehensive overview of the process of non-clinical pharmaceutical development and associated analytical controls and regulatory submission of a new drug candidate. The symposium will use case studies and examples to emphasize on the utilization of QbD principles and risk based concepts in pharmaceutical development and commercialization. Recognised speakers from around the globe from both industry as well as academia will focus on the CMC related development and challenges that face the pharmaceutical industry. It will touch on API, drug product, associated analytics, technology transfer and product and process monitoring. The speakers will use case studies and examples to emphasize on the utilization of QbD principles and risk based concepts in pharmaceutical development and commercialization.

Within this context, the attendees will become familiar with the key science and technologies that support the overall non-clinical drug development process. Upon completion of this focus on the science of drug development, the attendee will be able to:

  1. Better anticipate the challenges, choices and key decision-making steps that are faced by development teams in bringing a drug product to the market.

  2. Enhance familiarity in the areas of QbD and risk based approaches in the development of API, drug products, manufacturing processes, controls and continuous improvements.

  3. Better appreciation and understanding the interdependencies between the API properties, formulation design and performance and associated analytical controls;

  4. Enhance contribution on the overall product development plan with activities that are critical and relevant to his/her respective discipline.


Who Should Attend?

  • Scientists, Managers and Decision Makers from R&D, Manufacturing, QC, Analytical R&D

  • Formulation and Product development scientists

  • Chemical (API) Development scientists

  • Regulatory staff

  • Students and faculty from Pharmacy Schools


Confirmed speakers include Industry leaders and experienced professionals from Bristol Myers Squibb, Dr. Reddy's, Janssen, USP and many more.